| # | Software Requirements Specification | # | All References | Document Section |
| SRS-001 |
The software shall acquire the heart rate and the SpO2 value from the patient sensors at least once per second. |
SAD-010 |
The Measurement Module shall acquire the raw sensor signals, filter them, and publish one validated heart-rate and SpO2 sample per second to the other modules. |
5 Software Modules |
| SRS-002 |
The software shall display the current heart rate and SpO2 value on the bedside screen and shall refresh the displayed values at least once per second. |
SAD-011 |
The Display Module shall render the published samples and the alarm states on the bedside screen and shall refresh the screen at least once per second. |
5 Software Modules |
| SRS-003 |
The software shall raise an alarm within 3 seconds after a measured vital sign crosses its configured alarm limit. |
SAD-012 |
The Alarm Module shall compare every published sample against the configured alarm limits, shall manage the alarm state machine, and shall drive the visual and audible annunciators, including the bounded audible pause. |
5 Software Modules |
| SRS-004 |
The software shall annunciate an active alarm both visually and audibly; the audible annunciation may be paused for at most 60 seconds but shall not be permanently disabled. |
SAD-012 |
The Alarm Module shall compare every published sample against the configured alarm limits, shall manage the alarm state machine, and shall drive the visual and audible annunciators, including the bounded audible pause. |
5 Software Modules |
| SRS-005 |
The software shall store the measured vital signs of the last 72 hours as trend data and shall preserve the stored trend data across a power loss. |
SAD-013 |
The Trend Storage Module shall persist every published sample into a 72-hour trend store held in non-volatile memory. |
5 Software Modules |
| SRS-006 |
The software shall forward every measurement and every alarm event to the central nurse station over the hospital network. |
SAD-014 |
The Connectivity Module shall transmit published samples and alarm events to the nurse station and shall buffer them while the network is unavailable, isolating the safety core from network state. |
5 Software Modules |
| SRS-007 |
The software shall continue local measurement, display, and alarm annunciation without degradation while the hospital network is unavailable. |
SAD-001 |
Every safety function — measurement, display, and alarm annunciation — shall be performed locally on the device and shall not depend on the availability of the hospital network. |
2 Architecture Principles |
| SRS-007 |
The software shall continue local measurement, display, and alarm annunciation without degradation while the hospital network is unavailable. |
SAD-014 |
The Connectivity Module shall transmit published samples and alarm events to the nurse station and shall buffer them while the network is unavailable, isolating the safety core from network state. |
5 Software Modules |
| SRS-008 |
The software shall execute a self-test at every start-up and shall not enter the monitoring mode when the self-test fails. |
SAD-003 |
The software shall start in a fail-safe manner: monitoring is entered only after the start-up self-test has passed, and a supervision function monitors the safety core at run time. |
2 Architecture Principles |
| SRS-008 |
The software shall execute a self-test at every start-up and shall not enter the monitoring mode when the self-test fails. |
SAD-015 |
The System Supervisor shall execute the start-up self-test, shall gate the transition into monitoring mode on its result, and shall supervise the safety core modules at run time through a watchdog. |
5 Software Modules |
| SRS-009 |
The software shall record every alarm event, every settings change, and every detected fault in a persistent event log. |
SAD-016 |
The Configuration and Audit Module shall authenticate clinicians before permitting alarm-limit changes and shall write alarm events, settings changes, and detected faults into the persistent event log. |
5 Software Modules |
| SRS-010 |
The software shall allow changing the alarm limits only after the user has been authenticated as a clinician. |
SAD-016 |
The Configuration and Audit Module shall authenticate clinicians before permitting alarm-limit changes and shall write alarm events, settings changes, and detected faults into the persistent event log. |
5 Software Modules |